Health & Fitness (205)
The Supreme Court grapples Monday with the question of whether human genes can be patented. Its ultimate answer could reshape U.S. medical research, the fight against diseases like breast and ovarian cancer and the multi-billion dollar medical and biotechnology business.
"The intellectual framework that comes out of the decision could have a significant impact on other patents - for antibiotics, vaccines, hormones, stem cells and diagnostics on infectious microbes that are found in nature," Robert Cook-Deegan, director for genome ethics, law & policy at Duke University, said in a statement.
"This could affect agricultural biotechnology, environmental biotechnology, green-tech, the use of organisms to produce alternative fuels and other applications," he said.
The nine justices' decision will also have a profound effect on American business, with billions of dollars of investment and years of research on the line. The U.S. Patent and Trademark Office has been awarding patents on human genes for almost 30 years.
And Myriad Genetics alone has $500 million invested in the patents being argued over in this case. Without the ability to recoup that investment, breakthrough scientific discoveries needed to combat all kind of medical maladies wouldn't happen, the company says.
"Countless companies and investors have risked billions of dollars to research and develop scientific advances under the promise of strong patent protection," said Peter D. Meldrum, the president and CEO of Myriad Genetics, in a statement.
But their opponents argue that allowing companies like Myriad to patent human genes or parts of human genes will slow down or cripple lifesaving medical research like in the battle against breast cancer.
"What that means is that no other researcher or doctor can develop an additional test, therapy or conduct research on these genes," said Karuna Jagger, executive director of Breast Cancer Action.
The Supreme Court has already said that abstract ideas, natural phenomena and laws of nature cannot be given a patent, which gives an inventor the right to prevent others from making, using or selling a novel device, process or application.
Myriad's case involves patents on two genes linked to increased risk of breast and ovarian cancer. Myriad's BRACAnalysis test looks for mutations on the breast cancer predisposition gene, or BRCA. Those mutations are associated with much greater risks of breast and ovarian cancer.
Women with a faulty gene have a three to seven times greater risk of developing breast cancer and a higher risk of ovarian cancer. Men can also carry a BRCA mutation, raising their risk of prostate, pancreatic and other types of cancer. The mutations are most common in people of eastern European Jewish descent.
Myriad sells the only BRCA gene test.
The American Civil Liberties Union challenged Myriad's patents, arguing that genes couldn't be patented, and in March 2010 a New York district court agreed. But the U.S. Court of Appeals for the Federal Circuit has now twice ruled that genes can be patented. In Myriad's case, it's because the isolated DNA has a "markedly different chemical structure" from DNA within the body.
Mark C. Capone, president of Myriad Genetics Laboratories, Inc., a subsidiary of Myriad, said some of the concerns over what they have patented are overblown and some simply incorrect.
"Myriad cannot, should not and has not patented genes as they exist in the human body on DNA," Capone said in an interview. "This case is truly about isolated DNA molecules which are synthetic chemicals created by the human ingenuity of man that have very important clinical utilities, which is why this was eligible for a patent."
But the ACLU is arguing that isolating the DNA molecules doesn't stop them from being DNA molecules, which they say aren't patentable.
"Under this theory, Hans Dehmelt, who won the Nobel Prize for being the first to isolate a single electron from an atom, could have patented the electron itself," said Christopher A. Hansen, the ACLU's lawyer in court papers. "A kidney removed from the body (or gold extracted from a stream) would be patentable subject matter."
The Obama administration seems to agree. Artificially created DNA can be patented, but "isolated but otherwise unmodified genomic DNA is not patent-eligible," Solicitor General Donald Verrilli said in court papers.
That was the ruling of the original judge who looked at Myriad's patents after they were challenged by the ACLU in 2009. U.S. District Judge Robert Sweet said he invalidated the patents because DNA's existence in an isolated form does not alter the fundamental quality of DNA as it exists in the body or the information it encodes. But the federal appeals court reversed him in 2011, saying Myriad's genes can be patented because the isolated DNA has a "markedly different chemical structure" from DNA within the body.
The Supreme Court threw out that decision and sent the case back to the lower courts for rehearing. This came after the high court unanimously threw out patents on a Prometheus Laboratories, Inc., test that could help doctors set drug doses for autoimmune diseases like Crohn's disease, saying the laws of nature are unpatentable.
But the federal circuit upheld Myriad's patents again in August, leading to the current review. The court will rule before the end of the summer.
"The key issue now for the court will therefore be whether the scientist working in the lab to isolate a particular gene innovated in a way that allows for that isolated gene to be patented," said Bruce Wexler, a lawyer with the law firm Paul Hastings, who advises pharmaceutical and biotech companies on patent issues.
The case is 12-398, Association for Molecular Pathology v. Myriad Genetics, Inc.
WASHINGTON (AP) - A congressional investigation finds that specialty pharmacies like the one that triggered a deadly meningitis outbreak last year have little state oversight.
The report being released Monday by House Democrats shows that most states do not track or routinely inspect compounding pharmacies and that pharmacy boards in nearly all 50 states lack the information and expertise they need.
Missouri and Mississippi were the only two states that require permits or licenses and also the only ones with complete data on how many facilities they had.
None of the states indicated that they track whether pharmacies sell compounded drugs across state lines or in large quantities. Twenty-two states said they do not keep histories of problems.
Compounding pharmacies mix customized medications based on doctors' prescriptions. There have been calls for more federal oversight.
That long-ago safety scare, prompted by hundreds of lawsuits claiming birth defects, proved to be a false alarm.
Monday's FDA decision means a new version of the pill once called Bendectin is set to return to U.S. pharmacies under a different name - Diclegis - as a safe and effective treatment for this pregnancy rite of passage.
In the intervening decades, the treatment is widely believed to have undergone more scrutiny for safety than any other drug used during pregnancy.
"There's been a lot of buzz about this. Nothing better has come along" to treat morning sickness in those 30 years, said Dr. Edward McCabe, medical director for the March of Dimes, who welcomed the step.
"We know safety-wise, there's zero question," said Dr. Gary Hankins of the University of Texas Medical Branch in Galveston, who headed one of the company-financed studies of Diclegis that led to its approval.
U.S. sales of Diclegis are expected to begin in early June, according to Canada-based manufacturer Duchesnay Inc. The company has long sold a generic version of the pill in Canada under yet another name, Diclectin.
For all the names, the main ingredients are the same: Vitamin B6 plus the over-the-counter antihistamine doxylamine, found in the sleep aid Unisom. U.S. obstetricians have long told nauseated pregnant women how to mix up the right dose themselves.
In fact, in 2004 the American College of Obstetricians and Gynecologists issued guidelines calling the combination a first-line therapy.
The difference that prescription-only Diclegis would offer: Combining both ingredients with a delayed-release coating designed to help women take a daily dose before their nausea sets in.
The return of an FDA-cleared treatment is needed, said ACOG spokesman Dr. Jeffrey Ecker, an obstetrician at Massachusetts General Hospital who wasn't involved in the study of Diclegis.
"It's not magic," Ecker cautioned, saying few women see their symptoms completely disappear with the medication. "But for some it allows them to be much more functional."
In Hankins' study, about 260 U.S. women with morning sickness were given either Diclegis or a dummy pill for two weeks. The Diclegis users missed on average 1 1/2 fewer days of work than their counterparts.
Duchesnay wouldn't reveal a U.S. price.
About three-quarters of women experience at least some nausea and vomiting with the hormonal surges of early pregnancy. Although it often occurs upon waking, some women have trouble all day. It usually ends by the second trimester.
About 1 percent of women undergo dangerously severe vomiting called hyperemesis gravidarum, the condition that made headlines last December when in Britain, Prince William's wife Kate was briefly hospitalized.
An initial version of Bendectin began selling in 1956, and 33 million women around the world were estimated to have taken it before the lawsuits began. At the time, the FDA continued to call the drug safe; appeals courts ruled in favor of Bendectin maker Merrell Dow Pharmaceuticals; and eventually a U.S. Supreme Court decision would render continuing suits unlikely. But Merrell Dow declared the litigation cost too high, and quit making Bendectin in 1983.
What happened? The government estimates 1 in 33 babies are born with birth defects regardless of medication use during pregnancy, and studies eventually concluded that Bendectin didn't increase that baseline risk. McCabe of the March of Dimes says it's important to recognize that when a drug is widely used in pregnancy, some babies will be born with birth defects that are a coincidence.
Doctors advise trying some other steps before turning to medication for morning sickness: Eat protein snacks before bed. Nibble crackers or sip ginger ale before getting out of bed. Eat frequent small meals. Avoid nausea-triggering odors.
When that doesn't work, Ecker says vitamin B6 alone helps some women. His next step is the B6-and-antihistamine combination that will form Diclegis. A next-step option includes the drug Zofran, normally used to treat nausea from cancer therapy.
The figure is roughly twice the previous high estimate. But that's because the government last year lowered the threshold for lead poisoning, so now more children are considered at risk.
Too much lead can be harmful to developing brains and can mean a lower IQ. The new number released Thursday translates to about 1 in 38 young children.
After lowering the standard, the government went back and looked at blood tests from children under 6 to determine how many have lead poisoning under the new definition.
Lead poisoning has been a waning concern, as leaded gasoline, paint and other sources have diminished.
CDC report: HTTP://WWW.CDC.GOV/MMWR
The scientists, at several research institutes around the world, urged Chinese veterinary authorities to widely test animals and birds in affected regions to quickly detect and eliminate the H7N9 virus before it becomes widespread.
They said the virus is troubling because it can infect poultry without producing any symptoms, while seriously sickening humans. The virus, previously known to have infected only birds, appears to have mutated, enabling it to more easily infect other animals, including pigs, which could serve as hosts and spread the virus more widely among humans, they said.
The findings are preliminary and need further testing.
China over the weekend reported two deaths in Shanghai in the strain's first known infections of humans. On Wednesday it announced an additional fatality - a 38-year-old cook working in Jiangsu province, where other cases also have been reported.
The cook went home to Hangzhou in Zhejiang province for treatment after falling ill in early March, and died March 27.
One other person in Hangzhou, a 67-year-old retiree, was in critical condition, the official Xinhua News Agency reported, bringing the number of seriously ill H7N9 patients in three eastern provinces to six. Those regions stepped up measures this week to guard against the spread of the disease, calling on hospitals to report severe pneumonia cases with unknown causes and schools to monitor for fevers.
In the wake of the outbreak, the Chinese Center for Disease Control and Prevention shared the genetic sequence of the new virus with the global health community. The data allow scientists to make preliminary interpretations of how the virus might behave in different animals and situations. Such hypotheses, while not conclusive, can help provide important early warnings to authorities dealing with the disease.
The scientists said that based on information from the genetic data and Chinese lab testing, the H7N9 virus appears to infect some birds without causing any noticeable symptoms. Without obvious outbreaks of dying chickens or birds to focus efforts on, authorities could face a challenge in trying to trace the source of the infection and stop the spread.
"We speculate that when this virus is maintained in poultry the disease will not appear, and similar in pigs, if they are infected, so nobody recognizes the infection in animals around them, then the transmission from animal to human may occur," said Dr. Masato Tashiro, director of the World Health Organization's influenza research center in Tokyo and one of the specialists who studied the genetic data. "In terms of this phenomenon, it's more problematic."
This behavior is unlike the virus's more established relative, the virulent H5N1 strain, which set off warnings when it began ravaging poultry across Asia in 2003. H5N1 has since killed 360 people worldwide, mostly after close contact with infected birds.
"In that sense, if this continues to spread throughout China and beyond China, it would be an even bigger problem than with H5N1 in some sense, because with H5N1 you can see evidence of poultry dying, but here you can see this would be more or less a silent virus in poultry species that will occasionally infect humans," said University of Hong Kong microbiologist Malik Peiris, who also examined the information.
Scientists closely monitor bird flu viruses, fearing they may change and become easier to spread among humans, possibly sparking a pandemic. There's no evidence of that happening in China.
Peiris praised Chinese health authorities for being forthcoming with data and information, but said animal health agencies needed to act quickly. He urged China to widely test healthy birds in live animal markets in the parts of the country where the human infections have been reported to find out what bird species might be hosting the virus and stop the spread.
"If you don't stamp it out earlier now, there won't be any chance of stamping it out in the future," Peiris said. "It already may be too late, but this is the small window of opportunity that really one has to grasp, as quickly as possible."
The Agriculture Ministry's propaganda office could not be reached by phone and did not immediately respond to a faxed list of questions.
Other information gleaned from the genetic data was that the H7N9 virus was what scientists call a "gene re-assortant" - in which three bird viruses swapped genes among themselves - undergoing changes that allowed it to adapt more easily, though not fully, to human hosts, WHO's Tashiro said. One change has allowed it to lodge on the surfaces of cells of mammals, making it easier to infect humans.
"The tentative assessment of this virus is that it may cause human infection or epidemic. It is still not yet adapted to humans completely, but important factors have already changed," Tashiro said.
In China, the public is highly sensitized to news of infectious disease outbreaks, with many still recalling the SARS pneumonia scare a decade ago, when the government stayed silent while rumors circulated for weeks of an unidentified disease in southern Guangdong province. The cover-up contributed to the spread of the virus to many parts of China and to two dozen other countries, killing hundreds of people.
While many foreign health experts say China is being far more forthcoming this time than during the SARS scare, the government still faces credibility questions at home as it tries to juggle the need to respond to calls by the public for more information and the need to prevent unnecessary panic.
"The H7N9 bird flu is currently approaching. Ten years ago, the lesson learned in fighting SARS was: The greatest enemy is not the virus, but covering up the truth; the best medicine is not steroids, but transparency and trust," Yang Yu, a commentator with state broadcaster CCTV, said in a post on his microblog. "No matter what H7N9 is, now, the time to test the progress of Chinese society over the past 10 years has come."
Associated Press researcher Flora Ji contributed to this report. ---
Obama said the so-called BRAIN Initiative could create jobs and eventually lead to answers to ailments including Parkinson's and autism and help reverse the effect of a stroke. The president told scientists gathered in the White House's East Room that the research has the potential to improve the lives of billions of people worldwide.
"As humans we can identify galaxies light-years away," Obama said. "We can study particles smaller than an atom, but we still haven't unlocked the mystery of the three pounds of matter that sits between our ears."
BRAIN stands for Brain Research through Advancing Innovative Neurotechnologies. The idea, which Obama first proposed in his State of the Union address, would require the development of new technology that can record the electrical activity of individual cells and complex neural circuits in the brain "at the speed of thought," the White House said.
Obama wants the initial $100 million investment to support research at the National Institutes of Health, the Defense Advanced Research Projects Agency and the National Science Foundation. He also wants private companies, universities and philanthropists to partner with the federal agencies in support of the research. And he wants a study of the ethical, legal and societal implications of the research.
The goals of the work are unclear at this point. A working group at NIH, co-chaired by Cornelia "Cori" Bargmann of The Rockefeller University and William Newsome of Stanford University, would work on defining the goals and develop a multi-year plan to achieve them that included cost estimates.
Novartis had argued that it needed a patent to protect its investment in the cancer drug Glivec, while activists said the drug did not merit intellectual property protection in India because it was not a new medicine. In response to the ruling, Novartis said it would not invest in drug research in India.
The court's decision has global significance since India's $26 billion generic drug industry, which supplies much of the cheap medicine used in the developing world, could be stunted if Indian law allowed global drug companies to extend the lifespan of patents by making minor changes to medicines.
Once a drug's patent expires, generic manufacturers can legally produce it. They are able to make drugs at a fraction of the original manufacturer's cost because they don't carry out the expensive research and development.
Pratibha Singh, a lawyer for the Indian generic drug manufacturer Cipla, which makes a version of Glivec for less than a tenth of the original drug's selling price, said the court ruled that a patent could only be given to a new drug, and not to those which are only slightly different from the original.
"Patents will be given only for genuine inventions, and repetitive patents will not be given for minor tweaks to an existing drug," Singh told reporters outside the court.
Novartis called the ruling a "setback for patients," and said patent protection is crucial to fostering investment in research to develop new and better drugs.
Ranjit Shahani, the vice chairman and managing director of Novartis India, said the ruling "will hinder medical progress for diseases without effective treatment options."
He said the court's decision made India an even less attractive country for major investments by international pharmaceutical companies.
"Novartis will not invest in drug research in India. Not only Novartis, I don't think any global company is planning to research in India," he said.
The Swiss pharmaceutical giant has fought a legal battle in India since 2006 to patent a new version of Glivec, which is mainly used to treat leukemia and is known as Gleevec outside India and Europe. The earlier version of Glivec did not have an Indian patent because its development far predated the country's 2005 patent law. Novartis said Glivec is patented in nearly 40 other countries.
India's patent office rejected the company's patent application, arguing the drug was not a new medicine but an amended version of its earlier product. The patent authority cited a provision in the 2005 patent law aimed at preventing companies from getting fresh patents for making only minor changes to existing medicines - a practice known as "evergreening."
Novartis appealed, arguing the drug was a more easily absorbed version of Glivec and that it qualified for a patent.
Anand Grover, a lawyer for the Cancer Patients Aid Association, which led the legal fight against Novartis, said the ruling Monday prevented the watering down of India's patent laws.
"This is a very good day for cancer patients. It's the news we have been waiting for for seven long years," he said.
Aid groups, including Medicins Sans Frontieres, have opposed Novartis' case, fearing that a victory for the Swiss drugmaker would limit access to important medicines for millions of poor people around the world.
Glivec, used in treating chronic myeloid leukemia and some other cancers, costs about $2,600 a month. Its generic version was available in India for around $175 per month.
"The difference in price was huge. The generic version makes it affordable to so many more poor people, not just in India, but across the world," said Y.K. Sapru, of the Mumbai-based cancer patients association.
"For cancer sufferers, this ruling will mean the difference between life and death. Because the price at which it was available, and considering it's the only lifesaving drug for chronic myeloid cancer patients, this decision will make a huge difference," Sapru said.
Leena Menghaney of Medicins Sans Frontieres said India would continue to grant patents on new medicines.
"This doesn't mean that no patents will be granted. Patents will continue to be granted by India, but definitely the abusive practice of getting many patents on one drug will be stopped," Menghaney said.
The judgment would ensure that the prices of lifesaving drugs would come down as many more companies would produce generic versions.
"We've seen this happening with HIV medicines, where the cost of HIV treatment has come down from $10,000 to $150 per year. Cancer treatment costs have come down by 97 percent in the case of many cancer drugs," she said.
"This decision is incredibly important. The Supreme Court decision will save a lot of lives in the coming decades," Menghaney said. ---
AP writer Kay Johnson contributed to this story from Mumbai, India.